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Archive: TMF/eTMF Regulatory Agency Expectations, Inspections, and Findings

Course #: BI14617
September 10, 2021

Course Description

Recently the EMA has published guidance in managing the TMF. FDA’s regulations are general and require that sponsors and investigators maintain adequate and accurate records of any clinical investigations that are carried out. This web seminar will examine these expectations and discuss recent regulatory findings. We will also discuss strategies for implementing corrective and preventive actions (CAPAs) that result in successful outcomes to regulatory findings associated with TMF inspections.


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Learning Objectives

  • Explain regulatory expectations regarding TMF/eTMF management
  • Identify two recent regulatory findings directed at TMF/eTMF management
  • Describe strategies for preparing effective CAPAs that address regulatory findings
  • Discuss plan for preparing for a regulatory inspection

Who Should Attend

  • Good Clinical Practice Auditors and Quality Assurance Directors
  • Trial Master File Directors, Managers, and Coordinators
  • Clinical Operations Directors and Trial Managers
  • Records Management Team Members


Donna W. Dorozinsky, R.N., M.S.N., C.C.R.C.

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Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.